JP2018519884A - Compressible negative pressure source and method of use - Google Patents

Abstract

  Disclosed are systems, methods, and apparatus for applying negative pressure to a desired location. The device includes a flexible member, the flexible member being disposed within the inner cavity and an inflating force that is disposed within the inner cavity and applies a desired level of negative pressure to the wound. One or more compressible members configured to exert a pressure in the internal cavity.

Description

  Embodiments disclosed herein relate to devices, systems, and methods for applying negative pressure to a desired location, and in some embodiments, to a compressible negative pressure source used in negative pressure closure therapy.

  The treatment of open wounds or chronic wounds that do not heal, such as applying a negative pressure to the wound site and not closing naturally, is well known in the art. Negative pressure closure therapy (NPWT) systems currently known in the art generally place a fluid-impermeable or semi-permeable cover over the wound, using various means to treat the wound. Sealing the cover against surrounding patient tissue and connecting a negative pressure source (such as a vacuum pump) to the cover such that a negative pressure is generated and maintained under the cover. Such negative pressure promotes the formation of granulation tissue at the wound site and at the same time removes excess fluid that may contain harmful cytokines and / or bacteria while assisting the body's normal inflammatory processes This is believed to promote wound healing. However, further improvements in NPWT are needed to fully realize the therapeutic benefits.

  Many different types of wound dressings are known to aid NPWT systems. These various types of wound dressings include many different types of materials and layers, such as gauze, pads, foam pads, or multilayer wound dressings. An example of a multilayer wound dressing is the PICO dressing from Smith & Nephew, which includes a superabsorbent layer underneath the backing layer to form a canisterless system for treating wounds with NPWT. The wound dressing can be sealed against a suction port that provides a connection to the tubing, which can draw fluid from the dressing and / or transmit negative pressure from the pump to the wound dressing it can.

  Prior art devices that apply negative pressure are large, heavy, hard and difficult to use. Such devices often require a battery or power source to operate and can hinder user mobility.

U.S. Patent No. 9061095 PCT Patent Publication No.WO2011 / 144888A1 PCT Patent Publication No.WO2014 / 020440A1 U.S. Pat. WO2014 / 020440A1 (International Application No.PCT / IB2013 / 002060) U.S. Patent No. 9180231 U.S. Patent No. 9226737 PCT Patent Publication No. WO2013 / 175306A1 U.S. Patent Application Publication No. 2014/0249493 U.S. Patent Application Publication No. 2014/0228791 US Patent Application Publication No. 2013/0110058 U.S. Patent Application Publication No. 2015/0100045 WO2013 / 136181

According to some embodiments,
A fluid impermeable outer membrane defining an internal cavity;
One or more compressible members disposed within the internal cavity and including one or more compressible members configured to compress when air is removed from the internal cavity. A wound treatment device comprising a flexible member configured to apply pressure,
A wound treatment device is provided, wherein the one or more compressible members are configured to exert an expansion force in the internal cavity that applies a desired level of negative pressure to the wound after removing air from the internal cavity. The

  In some embodiments, the flexible member is a wound dressing further comprising a wound contact layer. The one or more compressible members can be disposed within an internal cavity defined between the fluid impermeable outer membrane and the wound contact layer. The wound dressing can further include a superabsorbent layer on the one or more compressible members. In some embodiments, the fluid impermeable outer membrane comprises a fluid impermeable upper membrane and a fluid impermeable lower membrane. The upper membrane and the lower membrane can be sealed together to form an internal cavity therebetween. In some embodiments, the fluid impermeable outer membrane can include a bag that defines an internal cavity. In some embodiments, the flexible member is configured to be wearable on a user's body. In some embodiments, the wound treatment device can further include a separate wound dressing configured to be positioned on the wound. The flexible member can be configured to be in fluid communication with a separate wound dressing and apply negative pressure to the wound through the separate wound dressing. A conduit can be in fluid communication with the internal cavity of the flexible member. The conduit may be configured to transmit negative pressure generated by the expansion force of the one or more compressible members to a separate wound dressing. A regulating valve can regulate the negative pressure supplied to the wound dressing by the internal cavity of the flexible member via the conduit. The internal cavity of the flexible member can apply a pressure of at least −400 mmHg to the regulating valve. In some embodiments, the one or more compressible members can include a plurality of constant tension springs. One or more compressible members can be incorporated into a 3D knitted or fabric material. The 3D knitted or fabric material can include a first fabric layer and a second fabric layer and a plurality of constant tension springs extending therebetween. The 3D knitted or fabric layer can include a top textured polyester layer, a bottom flat polyester layer, and a third fibrous layer therebetween, including one or more compressible members. In some embodiments, the one or more compressible members include foam. In some embodiments, the one or more compressible members are configured to exert an expansion force in the internal cavity that applies a pressure of at least -45 mmHg to the wound. In some embodiments, the device can include tubing connected to the flexible member. The tubing can form an air leak that allows air to be removed from the cavity. The device can include a valve that regulates the removal of air from the internal cavity. In some embodiments, air can be removed from the flexible member by squeezing the internal cavity of the flexible member. In some embodiments, a negative pressure source can remove air from the internal cavity of the flexible member. In some embodiments, the flexible member can include a port in fluid communication with the internal cavity. The port can communicate with a negative pressure source to remove air from the internal cavity. In some embodiments, the device can include an audible alarm system. The audible alarm system can sound when the pressure in the internal cavity of the flexible member rises above a predetermined negative pressure.

According to some embodiments,
Providing a flexible member comprising a fluid impermeable outer membrane defining an internal cavity and one or more compressible members disposed within the internal cavity;
Removing air from an internal cavity, the method comprising: generating one or more compressible members by removing air;
A method is provided in which one or more compressible members, after removing air from an internal cavity, exert an expansion force in the internal cavity to generate a negative pressure at a desired location.

  In some embodiments, air is removed from the internal cavity via tubing connected to the flexible member. The tubing can form a leak that allows air to be removed from the internal cavity. In some embodiments, air is removed from the internal cavity by a negative pressure source in fluid communication with the internal cavity. In some embodiments, air is removed from the internal cavity by squeezing the flexible member. In some embodiments, the one or more compressible members include foam. In some embodiments, the one or more compressible members can include a plurality of constant tension springs. One or more compressible members can be incorporated into a 3D knitted or fabric material. In some embodiments, the removal of air from the internal cavity is regulated by a valve. In some embodiments, the pressure in the internal cavity can be monitored and an alarm can be sounded when the pressure in the internal cavity rises above a predetermined negative pressure. In some embodiments, the one or more compressible members exert an expansion force in the internal cavity that applies at least -45 mmHg to the desired location. In some embodiments, the amount of negative pressure generated at the desired position can be adjusted by a regulating valve. The regulating valve can be placed between the flexible member and the desired position. In some embodiments, the one or more compressible members exert an expansion force in the internal cavity that applies at least −400 mmHg to the regulating valve.

  The invention will be more fully understood from the following detailed description and the accompanying drawings. These drawings are for the purpose of illustrating the present invention and are not intended to limit the present invention.

It is sectional drawing which shows embodiment of a compressible negative pressure source. It is a top view which shows embodiment of a compressible negative pressure source. It is an expanded view which shows embodiment of a compressible negative pressure source. It is a top view showing an embodiment of 3D cloth incorporating a plurality of compressible members. It is sectional drawing which shows embodiment of 3D cloth incorporating a some compressible member. It is a perspective view showing an embodiment of 3D cloth incorporating a plurality of compressible members. 1 shows an embodiment of a wound treatment device including a compressible negative pressure source and a wound dressing. FIG. 1 is a top view of an embodiment of a wound dressing that includes a compressible negative pressure source. FIG. 1 is a cross-sectional view illustrating an embodiment of a wound dressing including a compressible negative pressure source. It is an expanded view which shows embodiment of the wound dressing containing a compressible negative pressure source.

  Embodiments disclosed herein relate to an apparatus and method for treating a wound with reduced pressure, including a pump and a wound dressing component and apparatus. As used herein, these devices and components, including wound overlays and packing materials, may be collectively referred to as dressings.

  It will be understood that reference is made herein to wounds. The term “wound” is to be interpreted broadly, the skin is ripped, the skin is cut, or the skin is punctured, or the trauma is a contusion or any other in the patient's skin It should be understood that open and non-open wounds that cause other superficial or other conditions, or open and non-open wounds where other reduced pressure treatments are advantageous. Thus, a wound is broadly defined as any damaged tissue region where fluid may or may not be generated. Examples of such wounds include, but are not limited to, abdominal wounds, or other large or incision wounds due to surgery, trauma, sternotomy, fasciotomy or other circumstances , Dehiscence wound, acute wound, chronic wound, subacute dehiscence wound, traumatic wound, flap and skin graft, laceration, abrasion, contusion, burn, diabetic ulcer, decubitus ulcer, stoma, surgical wound, or Examples include traumatic and venous ulcers.

  It will be appreciated that embodiments of the present disclosure are generally applicable for use in a local negative pressure (“TNP”) therapy system. Simply put, negative pressure closure therapy reduces the tissue edema, promotes blood flow and granulation tissue formation, and removes excessive exudation to close and heal many forms of “hard to heal” wounds. And reduce the bacterial load (and thereby the risk of infection). Furthermore, this therapy can reduce healing with less interference to the wound. The TNP therapy system can also assist in the healing of surgically closed wounds by removing fluid and helping to stabilize the tissue in its exposed position of closure. A further advantageous application of TNP therapy is to find in skin grafts and flaps where removal of excess fluid is important and the graft must be in close proximity to the tissue to compensate for tissue survival. Can do.

  As used herein, reduced pressure or negative pressure levels such as -XmmHg represent pressure levels below standard atmospheric pressure corresponding to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Therefore, the negative pressure value of -XmmHg reflects an absolute pressure lower than 760 mmHg by XmmHg, in other words, an absolute pressure of (760-X) mmHg. Furthermore, a negative pressure of “less than” XmmHg or “lower” of XmmHg corresponds to a pressure closer to atmospheric pressure (eg, -40 mmHg is less than -60 mmHg). -XmmHg "above" negative pressure, or -XmmHg "higher" negative pressure corresponds to pressures farther from atmospheric pressure (for example, -80mmHg is a pressure above -60mmHg)

  The negative pressure range of some embodiments of the present disclosure can be between about -20 mmHg to -200 mmHg. Note that these pressures are relative to standard ambient atmospheric pressure. Therefore, -200 mmHg is actually about 560 mmHg. In some embodiments, the pressure range can be between about -40 mmHg to -150 mmHg. Alternatively, pressure ranges up to -75 mmHg, up to -80 mmHg, or above -80 mmHg can be used. In other embodiments, a pressure range of less than -75 mmHg can also be used. Alternatively, a pressure range greater than about -100 mmHg or 150 mmHg can be supplied by a negative pressure device.

  Embodiments of the wound dressing and wound treatment apparatus and method described herein also include, by reference, further details regarding wound dressings, wound dressing components and principles thereof, and embodiments of materials used in the wound dressing. U.S. Patent No. 9061095 entitled "WOUND DRESSING AND METHOD OF USE", PCT Patent Publication No. WO2011 / 144888A1 entitled "WOUND PROTECTION", PCT Patent entitled "WOUND DRESSING", which is incorporated herein in its entirety It can also be used in combination with or in addition to those described in Publication No. WO2014 / 020440A1.

  FIG. 1A is a diagram illustrating a cross-section of a compressible negative pressure source 100 according to an embodiment. A plan view as viewed from above the compressible negative pressure source 100 is shown in FIG. 1B together with a line AA showing the position of the cross section shown in FIG. 1A. FIG. 1C is a development view showing the compressible negative pressure source 100 of FIGS. 1A to 1B.

  1A-1C show the compressible negative pressure source 100 and its components as having a specific shape, but the structure of these layers is different in compressibility, for example, square, circular, elliptical, etc. The present invention can also be applied to the negative pressure source 100. As described above, the compressible negative pressure source 100 includes a fluid impermeable outer membrane 110 that forms an internal cavity 120 and a spacer layer that includes one or more compressible members disposed within the internal cavity 120. 130 and a tube 140 that communicates with the internal cavity 120 to form an air leak.

  The compressible negative pressure source 100 can be utilized to accumulate and apply negative pressure to the wound, as further described below. The compressible negative pressure source 100 includes a fluid impermeable outer membrane 110 that defines an internal cavity 120. In some embodiments, the fluid impermeable outer membrane includes a bag that defines an internal cavity. In other embodiments, the fluid-impermeable outer membrane can include an upper membrane and a lower membrane as shown in FIG. 1A, and these membranes are sealed along the periphery to form an internal cavity. To do. The upper and lower membranes can be sealed by any method known in the art, such as, for example, adhesive or welding techniques.

  In some embodiments, the fluid impermeable outer membrane 110 may include one or more polymeric films. In some embodiments, the fluid impermeable outer membrane 110 may comprise a polyurethane film, such as, for example, Elastollan SP9109. In other embodiments, the fluid-impermeable outer membrane 110 can comprise any sufficiently flexible and fluid-impermeable material that can define the inner cavity 120. As shown in FIG. 1B, the upper surface of the fluid-impermeable outer membrane 110 faces outwardly away from the center of the compressible negative pressure source 100 and surrounds a raised central region 112 that covers the spacer layer 130 described further below. It extends into the boundary region 111. As shown in FIG. 1B, the overall shape of the compressible negative pressure source 100 is a rectangle with rounded corners. It will be appreciated that the compressible negative pressure source according to other embodiments may have other shapes, such as square, circular, or oval.

  With continued reference to FIGS. 1A-1C, in some embodiments, the spacer layer 130 is disposed within an internal cavity 120 formed by the fluid-impermeable outer membrane 110. The spacer layer 130 includes one or more compressible members. As described further below, the one or more compressible members can include a plurality of constant tension springs. In some embodiments, the spacer layer 130 includes a material having a three-dimensional structure incorporating a plurality of compressible members, such as, for example, a 3D knitted or woven material that can incorporate a plurality of compressible members. it can. In some embodiments, the 3D knitted or woven fabric can be, for example, Baltex 7970 weft knitted polyester.

  2A-2C illustrate an embodiment of a spacer layer material that can be used in any of the compressible negative pressure source embodiments described herein. The spacer layer material is preferably composed of a material having a three-dimensional structure, and the upper layer constituting the mesh pattern (the “upper layer” is only used herein for reference, In use, any such top layer may not be located on top of any other layer) and bottom layer (the `` bottom layer '' is used herein for reference only) In use, any such bottom layer may not be located under any other layer). For example, knitted or woven spacers (eg Baltex 7970 weft knitted polyester) or non-woven fabrics can be used. In some embodiments, the top and bottom layers may not constitute a mesh pattern. The top and bottom layers can comprise polyesters such as 84/144 textured polyester or flat denier polyester. The top and bottom layers can also include gauze, foam, felt, or other fabric material. The spacer layer material can also have a third layer formed between the top layer and the bottom layer, which includes one of the one or more compressible members described above. It is a region defined by monofilament fibers such as knitted polyester viscose or cellulose. In some embodiments, other materials and other linear mass density fibers may be used in place of or in addition to the materials described above. In some embodiments, the top layer and the bottom layer may have the same pattern and material, and in other embodiments, the top layer and the bottom layer may have different patterns and / or different materials. In some embodiments, the top layer and the bottom layer have one or more of the spacer layer compressible members in contact with or perforated the fluid impermeable outer membrane 110. Can be prevented from opening. Furthermore, in some embodiments, the top and bottom layers can facilitate evaporation of wound exudate that is drawn into the dressing.

  FIG. 2A is a diagram illustrating the top or bottom layer of an exemplary 3D fabric spacer layer 130 in more detail. The 3D fabric spacer layer 130 includes a top knitted layer and a bottom knitted layer separated by a knitted structure. A mesh line is sometimes called a mesh course. The mesh rows are sometimes called wales. A single monofilament fiber is knitted into a 3D cloth to form a plurality of separated strands separating the two layers of the 3D cloth spacer layer 130. These fiber strands can act as constant tension springs and can constitute one or more compressible members.

  FIG. 2B is a diagram illustrating a cross-section of a portion of an embodiment of a spacer layer 130 that can be utilized with a compressible negative pressure source as shown in FIGS. 1A-1C. In particular, FIG. 2B is an enlarged view showing a fabric spacer layer 130 incorporating a plurality of compressible members. The top layer 201 of the fabric spacer layer 130 is spaced from the bottom layer 203. The top and bottom layers of the fabric spacer layer 130 separate the two layers of the fabric spacer layer 130 and act as elastic flexible pillars or constant tension springs that constitute the one or more compressible members described above. A plurality of monofilament fiber spacers 202 maintain a spaced relationship.

  As shown in the side view of FIG. 2B, there may be a plurality of filaments that act as constant tension springs between the top and bottom fabric layers. These filaments can include monofilament fibers or multi-strand fibers and can be knitted polyester viscose or cellulose. These filaments or constant tension springs constitute one or more compressible members of the spacer layer 130 described above. In some embodiments, the majority of the filaments by volume may extend vertically (ie, perpendicular to the planes of the top and bottom layers), or substantially or generally vertically. In another embodiment, 80% to 90% (or about 80% to about 90%) or more of the filaments by volume may extend vertically, substantially, or generally vertically. In another embodiment, all filaments or substantially all filaments by volume may extend vertically, substantially, or generally vertically. In some embodiments, most of the filaments or 80% to 90% (or about 80% to about 90%) or more, or all filaments or substantially all filaments are above the bottom fabric layer, and Extending downward from the top fabric layer, and in some embodiments, such filaments extend for more than half the distance between the top fabric layer and the bottom fabric layer. In some embodiments, the majority of filaments or 80% to 90% (or about 80% to about 90%) or more, or all or substantially all filaments are in the top and bottom fabric layers. The distance is greater in the direction (vertical direction) perpendicular to the upper and lower fabric layers than in the parallel direction (horizontal direction).

  FIG. 2C is a perspective view illustrating an embodiment of a 3D fabric spacer layer 130. FIG. A plurality of filaments 202 constituting one or more compressible members can be disposed between the top layer 201 and the bottom layer 203 as described above with reference to FIG. 2A.

  In other embodiments (not shown), the spacer layer 130 can include one or more compressible members that can include foam. For example, the one or more compressible members can include an open cell foam material. In some embodiments, the one or more compressible members can include multiple layers of open cell foam. In some embodiments, the foam is a reticulated open cell foam. In some embodiments, the spacer layer 130 can include two, three, four, or more foam layers. These foam layers may be integrally formed by, for example, selecting a foam having a large pore diameter, and repeatedly immersing this foam so that the portion to be immersed in the material that closes the hole becomes smaller each time. One or more compressible members comprising a plurality of foam layers by laminating different types of foams in layers or fixing such foam layers in place in a known manner May be formed.

  Referring again to FIG. 1A, in some embodiments, the compressible negative pressure source 100 allows tubing to remove air from the internal cavity 120 by forming an air leak in communication with the internal cavity 120. 140 can be included. Due to the non-breathability of the fluid-impermeable outer membrane 110, the internal cavity 120 constitutes a liquid-tight and air-tight cavity except for the air leakage portion formed by the tube material 140. Therefore, air that may be trapped in the internal cavity 120 can only exit the internal cavity 120 through the air leak formed by the tube 140.

  In some embodiments, the tubing 140 includes two ends, a first end that is in fluid communication with the internal cavity 120 and a second end that is in fluid communication with the surrounding environment. To exhaust air that may be contained within the inner cavity 120, air enters the first end of the tubing 140 from the inner cavity 120, passes through the tubing 140, and from the second end of the tubing 140. Must be in the surrounding environment. The fluid impervious outer membrane 110 and thus the inner cavity 120 is substantially airtight and liquid tight so that air contained in the inner cavity 120 escapes from the inner cavity 120 via any other path, or It is prevented from being removed. In embodiments where the fluid impermeable outer membrane 110 includes an upper membrane and a lower membrane, the tubing 140 can be sealed between these membranes in fluid communication with the internal cavity 120. In some embodiments, the tubing can communicate with the internal cavity 120 through a hole, orifice, or opening in the fluid impermeable outer membrane 110. In some embodiments, the tubing 140 can enter the inner cavity 120 through the fluid impermeable outer membrane 110. In some embodiments, the tubing 140 can communicate with the internal cavity 120 via a port or boss known in the art attached to the fluid impermeable outer membrane 110. Tubing 140 may be a single lumen conduit or a multi-lumen conduit.

  With continued reference to FIG. 1A, the tubing 140 includes a one-way valve (not shown) configured to prevent ambient air from flowing into the internal cavity 120 through a leak formed by the tubing 140. Further can be included. The one-way valve allows air to flow from the internal cavity 120 to the surrounding environment via the pipe 140, but can prevent air from flowing into the internal cavity 120 via the pipe 140. In this way, the one-way valve seals the internal cavity 120 from the surrounding environment and still allows air to be removed from the internal cavity 120 via the tubing 140, as described further below. Work so that any negative pressure within 120 can be maintained. The valve can be further configured to allow a desired amount of air to be removed or escape from the internal cavity 120. The desired amount of air can correspond to a desired level of negative pressure within the internal cavity 120. In some embodiments, the valve can include any such valve known in the art with the features described above.

  In some other embodiments, the leak of the internal cavity 120 may not include the tubing 140. The leak can include a hole, orifice, opening, or port in the fluid impermeable outer membrane 110 that is in fluid communication with the internal cavity 120. The air leak may include a one-way valve in fluid communication with the internal cavity 120 that is incorporated directly into the fluid impermeable outer membrane 110 as described above. The air leak may include a port (not shown) configured to communicate with a negative pressure source as described herein that is in fluid communication with the internal cavity 120. The port can be attached to the fluid impermeable outer membrane 110. The port can be attached to the fluid impermeable outer membrane 110 using techniques known in the art, such as adhesives or welding. In some embodiments, the port comprises a soft polymer, such as polyethylene, polyvinyl chloride, silicone, or polyurethane, having a Shore A hardness of 30 to 90. In some embodiments, the port is located over or in a hole, opening, or orifice in the fluid impermeable outer membrane 110, thereby fluidly communicating with the internal cavity 120.

  In operation, evacuation of air that may be contained in the internal cavity 120 is performed in various ways. As described above, air can escape from the internal cavity 120 only through a leak formed by the tubing 140 in the exemplary embodiment shown in FIGS. 1A-1C. Air can be pushed out of the internal cavity 120 through the tubing 140 by physically compressing the compressible negative pressure source 100 and thereby physically compressing the internal cavity 120. The physical compression of the internal cavity 120 effectively reduces the volume of the internal cavity 120, thereby allowing any air that may be contained in the internal cavity 120 to be leaked here, which is the tubing 140. Extrude through part. Physical compression of the internal cavity 120 can be achieved, for example, by squeezing the compressible negative pressure source 100. For example, the user can hold the compressible negative pressure source 100 in his hand and squeeze it to exhaust air from the internal cavity 120. Alternatively, the user may, for example, place the compressible negative pressure source 100 on a surface, such as the upper surface, of the compressible negative pressure source 100 with the relatively negative resistance surface, such as the user's body, positioned. Pressure may be applied. In some embodiments, as described above, the valve may prevent backflow of air into the internal cavity 120 through the leak after it has been removed from the internal cavity 120.

  A negative pressure source (not shown) can also be used to remove air from the internal cavity 120 via the tubing 140. A negative pressure source, such as a syringe, can be connected to the end of the tubing 140 that is in communication with the surrounding environment to establish a fluid connection between the negative pressure source and the internal cavity 120. In this state, the negative pressure source can apply a negative pressure to the internal cavity 120 via the tube 140. For example, the end of the syringe can be connected to the tubing 140 and the plunger of the syringe can be withdrawn to apply a negative pressure to the internal cavity 120. Air that may have been previously contained in the internal cavity 120 is drawn from the internal cavity 120 through the tubing 140 by a negative pressure source. In some embodiments, as described above, the valve may prevent ambient air from flowing back into the internal cavity 120 through the leak. In some other embodiments, where the compressible negative pressure source 100 includes a port, valve, or hole in the fluid impermeable outer membrane 110, the negative pressure source is attached to the port, valve, or hole, thereby providing the negative pressure source. Fluid communication can be established between the pressure source and the internal cavity 120. In these other embodiments, the negative pressure source can optionally be removed from fluid communication with the internal cavity 120 after the desired amount of air has been removed from the internal cavity 120. The negative pressure source can include any type of vacuum pump known in the art. The pump may be manually operated, and in other embodiments may be automatic or motorized. In some embodiments, the negative pressure source can also include a piston pump. In other embodiments, the negative pressure source can include a manually operated syringe.

  Any suitable mechanism is utilized to compress the spacer layer 130 including one or more compressible members by removing a sufficient amount of air from the inner cavity 120. Accordingly, in some embodiments, the spacer layer 130 shown in FIGS. 1A-1C is configured to compress when air is removed by application of negative pressure to the internal cavity 120. In some embodiments, the spacer layer 130 is configured to compress when a minimum level of negative pressure is applied to the internal cavity 120. The lowest level of negative pressure can be at least equal to the level of negative pressure applied by the expansion force of the one or more compression members, as further described below. In some embodiments, the lowest level of negative pressure is greater than the level of negative pressure applied by the expansion force of the one or more compressible members. In some embodiments, the one or more compressible members are configured to not compress until a negative pressure of at least -45 mmHg is applied to the internal cavity 120. In other embodiments, the one or more compressible members are configured to not compress until a negative pressure of at least -70 mmHg is applied to the inner cavity 120. In still other embodiments, the one or more compressible members are configured to not compress until a negative pressure of at least −400 mmHg is applied to the inner cavity 120.

  The compressed compression member or members that make up the spacer layer 130 then exert an expansion force in the internal cavity 120 that creates a level of negative pressure that can be transmitted to a desired location, such as a wound, for example. Configured. In some embodiments, when one or more compressible members are compressed, the one or more compressible members elastically deform so that the expansion force exerted by the one or more compressible members is , Corresponding to the stiffness of the one or more compressible members. The stiffness of the one or more compressible members is stiff enough to exert an expanding force when compressed that the compressed member can be used to apply the desired level of negative pressure to the desired location. It is preferable that it is such. However, it is preferred that the one or more compressible members are not so stiff that removing the air from the internal cavity 120 prevents the one or more compressible members from being compressed. Since the expansion force exerted by the one or more compressible members corresponds to the stiffness of the one or more compressible members, one can be selected by selecting one or more compressible members with the appropriate stiffness. Alternatively, the expansion force exerted by the plurality of compressible members can be changed.

  In some embodiments, the expansion force generated by one or more compressible members against the internal cavity 120 can be set to apply a negative pressure of at least -45 mmHg at the desired location. In other embodiments, the expansion force generated by one or more compressible members against the internal cavity 120 is set to apply a negative pressure of at least -70 mmHg at the desired location. In still other embodiments, the expansion force generated by the one or more compressible members against the inner cavity 120 applies a negative pressure between about -20 mmHg and about -200 mmHg at the desired location. Is set. In some embodiments, the expansion force generated by one or more compressible members against the internal cavity 120 is set to apply a negative pressure of up to −400 mmHg at the desired location.

  The expansion force generated by the one or more compressible members against the internal cavity can be used to transmit negative pressure from any suitable outlet to a desired location, such as a wound. One possible outlet may be tubing connected to the compressible negative pressure source 100. For example, the tubing 140 shown in FIGS. 1A-1C described above as forming an air leak may alternatively form a conduit that transmits negative pressure to the wound. In such embodiments, tubing 140 can include a valve that regulates the amount of negative pressure transmitted through the tubing to the wound, as described above. In some embodiments, separate tubing or conduits may be provided for leaks and negative pressure transmission, each of which may include a valve.

  In some embodiments, the compressible negative pressure source 100 further includes an audible alarm system configured to sound when the pressure in the internal cavity 120 rises above a predetermined negative pressure. In some embodiments, the audible alarm system is located within the tubing 140 of the compressible negative pressure source 100. In other embodiments, the audible alarm system is not located within the tubing. In some embodiments, the audible alarm system includes a valve that indicates that the pressure in the internal cavity 120 has risen above a predetermined level by emitting a sound at a predetermined negative pressure. In some embodiments, the audible alarm system does not include electronic components. In some embodiments, the audible alarm system may include electronic components such as speakers.

  In some embodiments, the compressible negative pressure source 100 may further include a luminescent alarm system configured to emit light when the pressure in the internal cavity 120 rises above a predetermined negative pressure. In other embodiments, the compressible negative pressure source 100 includes a luminescent alarm and may not include an audible alarm. In certain embodiments, an audible alarm system and a light emitting alarm system are integrated. The light emitting alarm may include a light source such as a light emitting diode (LED). In some embodiments, the luminescent alarm can include a sensor that detects when the pressure in the internal cavity 120 rises above a predetermined negative pressure. The light source can be located on the outer surface of the compressible negative pressure source 100 so that it can be seen by the user when emitting light. For example, the light source can be located on the fluid impermeable outer membrane 110.

  In some embodiments, the compressible negative pressure source 100 is configured to be wearable on, for example, a user's body. In some embodiments, the compressible negative pressure source 100 is configured to be secured to the user's body. In some embodiments, the compressible negative pressure source 100 is an adhesive (not shown) configured to adhere the compressible negative pressure source 100 to the user's body during use of the compressible negative pressure source 100. Is further included on the fluid-impermeable outer membrane 110. In some embodiments, the adhesive on the fluid impermeable outer membrane 110 can be configured to adhere the compressible negative pressure source 100 to the user's skin.

  In some embodiments, the compressible negative pressure source 100 can further include a pressure monitor such as the pressure monitor described in US Pat. No. 7,784,141, which is hereby incorporated by reference in its entirety. In some embodiments, the pressure monitor can include a plurality of protrusions on the fluid impermeable outer membrane 110 for monitoring the pressure in the internal cavity 120. In some embodiments, the plurality of protrusions are spaced apart and configured to indicate whether a predetermined level of negative pressure is obtained within the internal cavity 120.

  FIG. 3 is a diagram illustrating an embodiment of a wound treatment apparatus 300 and a wound dressing 310 that includes a compressible negative pressure source 100 similar to the compressible negative pressure source shown in FIGS. 1A-1C. The wound dressing 310 can be, for example, the wound dressing described in US Pat. No. 9061095, which is hereby incorporated by reference in its entirety. The wound dressing 310 can also be, for example, a wound dressing described in International Application No. PCT / IB2013 / 002060 published as WO2014 / 020440A1, which is hereby incorporated by reference in its entirety. The wound dressing 310 can also include one or more adhesive liquid-impermeable backing layers configured to maintain a seal over the wound.

  In some embodiments, the compressible negative pressure source 100 includes a conduit 360 that is in fluid communication with the internal cavity 120 of the compressible negative pressure source 100. The conduit 360 transmits the negative pressure generated by the expansion force of one or more compressible members of the compressible negative pressure source 100 to a desired location, such as the wound dressing 310. In embodiments where the fluid impermeable outer membrane 110 includes an upper membrane and a lower membrane, the conduit 360 can be sealed between these membranes in fluid communication with the internal cavity 120. In some embodiments, the conduit 360 can pass through a hole, orifice, or opening in the fluid impermeable outer membrane 110 and may or may not extend into the internal cavity 120. In some embodiments, the conduit 360 can communicate with the internal cavity 120 via a port or boss known in the art attached to the fluid impermeable outer membrane 110. The conduit 360 may be a single lumen conduit or a multi-lumen conduit. Thus, the compressible negative pressure source 100 is in fluid communication with the wound dressing 310 via the conduit 360. In some embodiments, the wound dressing 310 is configured to be positioned over the wound and the compressible negative pressure source 100 applies a negative pressure to the wound via a separate wound dressing 310. Configured as follows. Both the wound dressing 310 and the compressible negative pressure source 100 can also be configured to be wearable on the user's body as described above herein during use of the wound treatment device 300.

  As shown in FIG. 3, the wound treatment apparatus 300 is disposed between the wound dressing 310 and the compressible negative pressure source 100 and is in fluid communication with both the wound dressing 310 and the internal cavity 120 of the compressible negative pressure source 100. A regulating valve 370 may be further included. The conduit 360 that connects the wound dressing 310 to the compressible negative pressure source 100 may further include a regulating valve 370. The regulating valve 370 can be configured to regulate the negative pressure supplied from the internal cavity 120 to the wound dressing 310. That is, in some embodiments, the regulator valve 370 is configured to selectively open and close to regulate the level of negative pressure supplied to the wound dressing 310 from the compressible negative pressure source 100. In some embodiments, the regulator valve 370 is substantially the same and functions in substantially the same manner as the reservoir valve described in US Pat. No. 9,802,231, which is hereby incorporated by reference in its entirety.

  In some embodiments where the wound treatment device 300 includes a regulating valve 370, the compressible negative pressure source 100 can act as a negative pressure reservoir. For example, the compressible negative pressure source 100 can be configured to apply a negative pressure to the regulator valve 370 that is higher than a value that may be desirable to apply to the wound dressing 310. The regulating valve 370 is configured to adjust the level of negative pressure applied to the wound dressing so that a desired level of negative pressure is applied to the wound dressing 310. The regulating valve 370 opens and closes selectively according to the negative pressure of the wound dressing 310, and opens when the negative pressure of the wound dressing 310 rises above a predetermined threshold value to open the compressible negative pressure source 100. Can be configured to transmit negative pressure to the wound dressing 310. When the negative pressure of the wound dressing 310 reaches a predetermined level, the regulating valve 370 closes and stops or sufficiently adjusts the negative pressure from the compressible negative pressure source 100 to cause an unnecessarily large negative pressure. It is configured to prevent application to the wound dressing 310.

  The device 300 shown in FIG. 3 can be used to treat a patient's wound site. The healthy skin around the wound site 301 is preferably washed and excess hair is removed or shaved. The wound site 301 may be washed with sterile saline if necessary. Optionally, a skin protectant may be applied to the skin surrounding wound site 301. If necessary, a wound packing material such as foam or gauze may be located at the wound site 301. This may be preferred when the wound site 301 is a deep wound.

  After the skin surrounding the wound site 301 is dry, the wound dressing 310 can be positioned and positioned to cover the wound site 301. Preferably, the wound dressing 310 is placed with the wound contact layer 311 (if present) covering the wound site 301 and / or in contact with the wound site 301. In some embodiments, an adhesive layer is provided on the lower surface of the wound contact layer 311 and, in some cases, this adhesive layer is removed prior to placing the wound dressing 310 over the wound site 301. Can be protected by an optional release layer. The conduit 360 can be fluidly connected to the dressing using any suitable method. In one embodiment, the dressing 310 is such that the connection between the conduit 360 and the dressing 310 is made at an elevated position relative to the rest of the dressing 310 to avoid fluid buildup around the connection. To be positioned. In some embodiments, dressing 310 is positioned such that the connection between conduit 360 and dressing 310 does not rest directly on the wound and is at the same height as the wound or higher than the wound. In one embodiment, the conduit 360 is coated using a soft, flexible port as described in U.S. Patent No. 9226737 and PCT Patent Publication No. WO2013 / 175306A1, which are hereby incorporated by reference in their entirety. Can be connected to the material. To help ensure a sufficient seal of the TNP, the edge of the dressing 310 is preferably smoothed to avoid wrinkling or bending.

  With continued reference to FIG. 3, the compressible negative pressure source 100 can then be connected to the wound dressing 310 via a conduit 360. Alternatively, the conduit 360 may already be connected to the compressible negative pressure source 100. The first end of the conduit 360 can be connected to the wound dressing 310 to form fluid communication between the wound site 301 and the conduit 360 through the wound dressing 310. The second end of the conduit 360 can be connected to the compressible negative pressure source 100 so that the conduit 360 is in fluid communication with the internal cavity 120. The wound dressing 310 may be connected to the conduit 360 prior to the compressible negative pressure source 100, or the compressible negative pressure source 100 may be connected to the conduit 360 prior to the wound dressing 310, Alternatively, both the wound dressing 310 and the compressible negative pressure source 100 may be connected to the conduit 360 at the same time. Alternatively, in some embodiments, the wound treatment device 300 is a single unit configured to be applied to a wound site with the wound dressing 310 and the compressible negative pressure source 100 already connected by a conduit 360. It can also be provided as an integral unit.

  Optionally, the compressible negative pressure source 100 is secured in a position substantially close to the wound site 301 of the user's body after the wound dressing 310 is secured over the wound site 301 of the user's body. You can also Preferably, the compressible negative pressure source 100 is configured so that the conduit 360 can span the distance between the compressible negative pressure source 100 and the wound dressing 310 and the wound site 301 and wound dressing 310 of the user's body. It is fixed at a position close enough. The position of the compressible negative pressure source 100 in the user's body is relative to the compression of the compressible negative pressure source 100, whether by squeezing, by physical pressure, or by a negative pressure source. It is preferable to be selected so as to enhance the ease of use. As described above, compressible negative pressure source 100 may include an adhesive on the lower surface of fluid impermeable outer membrane 110 that adheres compressible negative pressure source 100 to the user's skin. Any alternative means of securing the compressible negative pressure source 100 known in the art to the user's skin or body may be used. Furthermore, the length of the conduit 360 should be selected based on the preferred location of the compressible negative pressure source 100 relative to the location of the wound dressing 310 in the user's body so as to prevent tangling due to the conduit 360 being too long. Can do.

  Once wound dressing 310 is secured over wound site 301, compressible negative pressure source 100 is optionally secured to the user's body, and wound dressing 310 is connected to compressible negative pressure source 100 by conduit 360. The compressible negative pressure source 100 can be operated to supply negative pressure to the wound dressing 310. A sufficient amount of air is removed from the internal cavity 120 of the compressible negative pressure source 100 by any suitable mechanism as described above. For example, the user may apply a uniform pressure to the surface of the compressible negative pressure source 100 by hand, or a negative pressure source such as a syringe may be connected to the compressible negative pressure source 100. By removing a sufficient amount of air, the spacer layer 130 including one or more compressible members is compressed as described above. The compressed one or more compressible members that make up the spacer layer 130 are then configured to exert an expansion force in the internal cavity 120 that produces a level of negative pressure that is then applied to the conduit. To the wound dressing 310. This negative pressure is then applied to the wound site 301 by the wound dressing 310.

  Treatment of wound site 301 is preferably continued until the wound reaches a desired level of healing. The level of negative pressure at the wound site 301 may decrease over time, and this may occur in part at the seal between the wound dressing 310 and the skin surrounding the wound site 301 It may be due to a slight leak. As the level of negative pressure at the wound site 301 decreases, the compressible negative pressure source 100 can be recompressed to continue applying the desired level of negative pressure to the wound site 301 through the wound dressing. The compressible negative pressure source 100 can be operated multiple times as described above to continue applying negative pressure to the wound site 301, as one skilled in the art may consider it necessary. In some embodiments, it may be desirable to replace the wound dressing 310 after a certain period of time has elapsed or when the dressing is full of wound fluid. During such replacement, the compressible negative pressure source 100 can be maintained and only the wound dressing 310 can be replaced.

  FIG. 4A is a cross-sectional view of a wound dressing 400 according to another embodiment. A plan view seen from above of the wound dressing 400 is shown in FIG. 4B together with a line BB indicating the position of the cross section shown in FIG. 4A. FIG. 4C is a development view showing the wound dressing 400 of FIGS. 4A and 4B.

  Referring to FIG. 4A, the wound dressing 400 includes an optional wound contact layer 460 and a fluid impermeable outer membrane 410. The wound contact layer 460 and the fluid impermeable outer membrane 410 can be bonded together to define an internal cavity 420. A permeable layer 430 comprising one or more compressible members is disposed within an internal cavity 420 of a wound dressing 400 similar to that described above and further described below. In some embodiments, the wound dressing 400 further includes an absorbent layer 450 disposed on the permeable layer 430 within the internal cavity 420. In some other embodiments, the absorbent layer 450 can be disposed below the permeable layer 430. In some embodiments, the absorbent layer 450 can also be disposed between one or more upper transmission layers and one or more lower transmission layers. The wound dressing 400 can be located over the wound site to be treated. The dressing 400 forms a sealed cavity over the wound site. An adhesive may also be provided on the lower surface of the outer membrane and / or wound contact layer 460 to adhere the wound dressing to the skin surrounding the wound.

  In some embodiments, it may be preferable to partially or completely fill the wound site with the wound packing material. This wound packing material is optional, but may be desirable for certain wounds, such as deep wounds. The wound packing material can be used in addition to the wound dressing 400. The wound packing material can generally comprise a porous comfortable material such as foam (including reticulated foam) or gauze. Preferably, the wound packing material is sized or shaped to fit within the wound site to fill any open space. The wound dressing 400 can then be placed over the wound site and the wound packing material that rests on the wound site. When using a wound packing material, negative pressure is transmitted from the wound dressing 400 through the wound packing material to the wound site after the wound dressing 400 is sealed over the wound site. This negative pressure draws wound exudate and other fluids or secretions from the wound site.

  With continued reference to FIG. 4A, in embodiments including a wound contact layer 460, the wound contact layer 460 has been perforated, for example, by a hot pin process, a laser ablation process, an ultrasonic process, or some other method, or other shape. Can be a polyurethane layer or a polyethylene layer or other flexible layer that is permeable to liquids and gases. The perforations 461 are through holes in the wound contact layer 460 that allow fluid to flow through the wound contact layer 460. The wound contact layer 460 helps prevent tissue ingrowth into other materials of the wound dressing. The perforations 461 are small enough to meet this requirement, but still allow fluid to pass through. For example, perforations formed as slits or holes with a size ranging from 0.025 mm to 1.2 mm prevent tissue ingrowth into the wound dressing while allowing wound exudate to flow into the dressing It is considered small enough to help. The wound contact layer 460 helps maintain the entire wound dressing together and creates a hermetic seal around the absorbent pad to help maintain negative pressure at the wound. Wound contact layer 460 also acts as a carrier for an optional adhesive layer (not shown). For example, a pressure sensitive adhesive can be provided on the lower surface of the wound contact layer 460. The pressure sensitive adhesive can be a silicone, hot melt, hydrocolloid, or acrylic based adhesive, or other such adhesive. Utilizing an adhesive helps to adhere the wound dressing 400 to the skin around the wound site.

  In some embodiments, the fluid impermeable outer membrane 410 is substantially the same as the fluid impermeable outer membrane 110 described hereinabove. In some embodiments, the fluid impermeable outer membrane 410 is sealed along the periphery to the wound contact layer 460 to form an internal cavity 420. As can be seen from FIG. 4B, the upper surface of the fluid-impermeable outer membrane 410 faces outwardly away from the center of the dressing and border region 411 that surrounds the central raised region 412 that covers the permeable layer 430 and the absorbent layer 450. Extending in. As shown in FIG. 4B, the overall shape of the wound dressing 400 is a rectangle with rounded corner areas. It will be appreciated that wound dressings according to other embodiments may have different shapes, such as square, round, or oval dressings.

  As shown in FIG. 4A, the permeable layer 430 comprising one or more compressible members can be substantially the same as the spacer layer 130 described herein above with reference to FIGS. 1A-1C. . The permeable layer 430 can include one or more compressible members. As described further below, the one or more compressible members can include a plurality of constant tension springs. In some embodiments, the permeable layer 430 includes a material having a three-dimensional structure that incorporates a plurality of compressible members, such as, for example, a 3D knitted or woven material that can incorporate a plurality of compressible members. it can. In some embodiments, the 3D knitted or woven fabric can be, for example, Baltex 7970 weft knitted polyester.

  In some embodiments, the permeable layer 430 is a top layer that is 84/144 textured polyester (the “top layer” is only used herein for reference, and any other in use. Any such top layer may not be located on the top layer) and a bottom layer (the `` bottom layer '') that is 100 denier flat polyester, referred to herein. One or more of the compressible members described above), and in use, any such bottom layer may not be located under any other layer in use) A 3D polyester permeable layer comprising a third layer sandwiched between the two layers, which is a region defined by monofilament fibers such as knitted polyester viscose or cellulose constituting one of the Can be included. In some embodiments, other materials and other linear mass density fibers may be used in place of or in addition to the materials described above.

  The 3D fabric permeable layer 430 can incorporate a plurality of compressible members. The top layer of the fabric permeable layer 430 is spaced from the bottom layer. The top and bottom layers of the fabric permeable layer 430 separate the two layers of the fabric permeable layer 430 and act as elastic flexible pillars or constant tension springs that constitute the one or more compressible members described above. A plurality of monofilament fiber spacers maintain a spaced relationship.

  A plurality of filaments that can act as constant tension springs can be disposed between the upper fabric layer and the bottom fabric layer of the transmission layer 430. These filaments can include monofilament fibers or multi-strand fibers and can be knitted polyester viscose or cellulose. These filaments or constant tension springs constitute one or more compressible members of the permeable layer 430 described above. In some embodiments, the majority of the filaments by volume may extend vertically (ie, perpendicular to the planes of the top and bottom layers), or substantially or generally vertically. In another embodiment, 80% to 90% (or about 80% to about 90%) or more of the filaments by volume may extend vertically, substantially, or generally vertically. In another embodiment, all filaments or substantially all filaments in volume may extend vertically, substantially, or generally vertically. In some embodiments, most of the filaments or 80% to 90% (or about 80% to about 90%) or more, or all filaments or substantially all filaments are above the bottom fabric layer, and Extending downward from the top fabric layer, and in some embodiments, such filaments extend for more than half the distance between the top fabric layer and the bottom fabric layer. In some embodiments, the majority of filaments or 80% to 90% (or about 80% to about 90%) or more, or all or substantially all filaments are in the top and bottom fabric layers. The distance is greater in the direction (vertical direction) perpendicular to the upper and lower fabric layers than in the parallel direction (horizontal direction).

  As shown in FIG. 4A, the permeable layer 430 is located above the wound contact layer 460. In addition to including one or more compressible members, this layer is capable of permeable to fluids, including liquids and gases, from the wound site into the one or more layers of the wound dressing 400. Further configured. In particular, the permeable layer 430 ensures that an open channel that transmits negative pressure over the wound area can be maintained even when the absorbent layer absorbs a large amount of exudate. This layer must remain open under normal pressure to be applied during negative pressure closure therapy, as described above, so that a uniform negative pressure is applied across the wound site.

  In some embodiments, the top fabric layer of the permeable layer 430 is used to form a bottom fabric layer in the yarn used to form it to control moisture flow through the permeable layer 430. It is possible to have more filaments than the number of filaments that make up the yarn used. In particular, by increasing the number of filaments in the top layer, i.e. by constructing the top layer with yarns that contain more filaments than the yarn used in the bottom layer, the liquid will flow along the top layer rather than the bottom layer. There is a tendency to be sucked up. Such filament orientation can facilitate the uptake of fluid in the permeable layer 430 in the vertical direction. In some embodiments, the ratio of the amount of fluid drawn up vertically through the permeable layer material to the amount of fluid drawn up laterally through the permeable layer material under negative pressure is 2: 1 or more, or about 2: 1 Or, in some embodiments, up to 10: 1 or more, or about 10: 1 or more.

  Preferably, to improve the liquid flow through the permeable layer 430 (i.e. orthogonal to the channel region formed between the top spacer layer and the bottom spacer layer), the 3D cloth is dry-cleaning agent (limited to this) Any manufactured products such as mineral oils, fats, and / or waxes that may have been treated with (such as perchlorethylene, but not interfered with) the hydrophilic function of the permeable layer. Help to remove. In some embodiments, an additional manufacturing step is then performed in which the 3D permeable layer fabric is subsequently washed with a hydrophilic agent (such as but not limited to Ferran Ice 30 g / l from Rudolph Group). be able to. This process step helps to ensure that the surface tension of the material is so low that a liquid such as water can penetrate as soon as it contacts the 3D knitted fabric. This also helps in controlling the flow of any exudate liquid insult component.

  In some embodiments, the wound dressing 400 includes an absorbent layer 450 disposed on the permeable layer 430 within the internal cavity 420. In some other embodiments, the absorbent layer 450 may be disposed below the permeable layer 430 or may be positioned between multiple permeable layers. In some embodiments, the absorbent layer 450 is substantially the same as, for example, the absorbent layer 110 shown in FIGS. 1A and 1B of US Pat. No. 9061095, which is hereby incorporated by reference in its entirety. . In other embodiments, the absorbent layer 450 is an absorbent as shown, for example, in FIGS. 3A-3B of International Application No. PCT / IB2013 / 002060 published as WO2014 / 020440A1, which is hereby incorporated by reference in its entirety. Agent layer 2110, such as the absorbent layer 402 shown in FIGS. 5-12, such as the absorbent layer 2308 shown in FIGS.24A-24F, such as the absorbent layer 503 shown in FIGS.25A-25B, such as FIGS. The absorbent layer 3440 shown in FIG. 34B and, for example, the absorbent layer 3940 shown in FIGS. 39A-39B can be substantially the same.

  Referring again to FIG. 4A, the absorbent layer 450 is configured to collect wound exudate that passes through the wound contact layer 460 and the permeable layer 430 from the wound. The absorbent layer 450 can comprise a foam or non-woven natural or synthetic material, and can optionally include a superabsorbent material or can be a superabsorbent material. In use, the absorbent layer 450 provides a reservoir of fluids, particularly liquids, that are removed from the wound site and withdraws these fluids toward the fluid impermeable outer membrane 410. The absorbent layer material also prevents the liquid collected in the wound dressing from splashing away. Absorbent layer 450 also helps disperse fluid throughout the layer by a wicking action so that fluid is extracted from the wound site and accumulates throughout the absorbent layer. This helps to prevent agglomeration in the region of the absorbent layer. The volume of absorbent material must be sufficient to manage the wound exudate flow rate when negative pressure is applied. Since the negative pressure is applied to the absorbent layer in use, the material of the absorbent layer is selected to absorb the liquid in such a situation. There are several materials that can absorb liquids under negative pressure, for example superabsorbent materials. The absorbent layer 450 can typically be manufactured from ALLEVYN® foam, Freudenberg 114-224-4, and / or Chem-Posite® 11C-450.

  Referring again to FIG. 4A, in some embodiments, the wound dressing 400 includes a tubing 440 that allows air to be removed from the internal cavity 420 by forming a leak in communication with the internal cavity 420. Can be included. Due to the non-breathability of the fluid-impermeable outer membrane 410, the internal cavity 420 constitutes a liquid-tight and air-tight cavity except for the air leakage part formed by the tube material 440. Accordingly, air that may be trapped in the internal cavity 420 can only exit the internal cavity 420 through the air leak formed by the tube 440. The tubing 440 can be substantially similar to the tubing 140 described with reference to FIGS. 1A-1C and can operate substantially similarly.

  Tubing 440 includes two ends, a first end in fluid communication with internal cavity 420 and a second end in fluid communication with the surrounding environment. To exhaust air that may be contained within the inner cavity 420, air enters the first end of the tubing 440 from the inner cavity 420, passes through the tubing 440, and from the second end of the tubing 440. Must be in the surrounding environment. With continued reference to FIG. 4A, the tubing 440 includes a one-way valve (not shown) configured to prevent ambient air from flowing into the internal cavity 420 through a leak formed by the tubing 440. Further can be included. The one-way valve can be substantially the same as the one-way valve described above with reference to FIGS. 1A-1C and can operate in substantially the same manner. The one-way valve allows air to flow from the inner cavity 420 to the surrounding environment via the tube 440, but prevents air from flowing into the inner cavity 420 via the tube 440.

  In some other embodiments, the leak of the internal cavity 420 may not include the tubing 440. The air leak may include a hole, orifice, or opening in the fluid impermeable outer membrane 410 that is in fluid communication with the internal cavity 420. This air leakage portion may be substantially the same as the air leakage portion described above with reference to FIGS. 1A to 1C.

  Referring now to FIG. 4C, as shown, the fluid impermeable outer membrane 410 of this embodiment does not include a port that connects the wound dressing 400 to an external negative pressure source. Unlike existing wound dressings, no negative pressure is applied to the wound from an external source, so the wound dressing 400 does not require a port to connect to the external negative pressure source. Instead, as described further below, negative pressure is applied directly to the wound by the dressing itself.

  Referring again to FIG. 4A, in operation, the exhaust of air that may be contained in the internal cavity 420 may be performed in various ways. As described above, air can escape from the internal cavity 420 only through the leak formed by the tubing 440 in the exemplary embodiment shown in FIGS. 4A-4C. Air can be pushed out of the internal cavity 420 through the tubing 440 by physically compressing the wound dressing 400 and thereby physically compressing the internal cavity 420. The physical compression of the inner cavity 420 effectively reduces the volume of the inner cavity 420, thereby allowing any air that may be contained in the inner cavity 420 to be leaked here, which is the tubing 440. Extrude through part. Physical compression of the internal cavity 420 can be achieved by a mechanism similar to that described above with respect to the compressible negative pressure source 100 of FIGS. 1A-1C, such as squeezing the wound dressing 400, for example. For example, the user may apply pressure to a surface such as an upper surface of the wound dressing 400 in a state where the user is positioned so as to cover the wound site. In some embodiments, as described above, the valve may prevent ambient air from flowing back into the internal cavity 420 through the leak after the air has been removed from the internal cavity 420.

  In some other embodiments, or alternatively, a negative pressure source (not shown) can optionally be used to remove air from the internal cavity 420 via the tubing 440. A negative pressure source, such as a syringe, can be connected to the end of the tubing 440 that is in communication with the surrounding environment to establish a fluid connection between the negative pressure source and the internal cavity 420. In this state, the negative pressure source can apply a negative pressure to the internal cavity 420 via the tube 440. For example, the end of the syringe can be connected to the tubing 440 and the plunger of the syringe can be withdrawn to apply negative pressure to the internal cavity 420. Air that may have been previously contained in the internal cavity 420 is drawn from the internal cavity 420 through the tubing 440 by a negative pressure source. In some embodiments, as described above, the valve can prevent ambient air from flowing back into the internal cavity 420 through the leak. In these other embodiments, the negative pressure source can optionally be removed from fluid communication with the internal cavity 420 after the desired amount of air has been removed from the internal cavity 420. The negative pressure source can include any type of vacuum pump known in the art. The pump may be manually operated, and in other embodiments may be automatic or motorized. In some embodiments, the negative pressure source can also include a piston pump. In other embodiments, the negative pressure source can include a manually operated syringe.

  With continued reference to FIG. 4A, any suitable mechanism is utilized to compress the permeable layer 430 including one or more compressible members by removing a sufficient amount of air from the inner cavity 420. Accordingly, in some embodiments, the permeable layer 430 shown in FIGS. 4A-4C is configured to compress when air is removed by application of negative pressure to the internal cavity 420. In some embodiments, the permeable layer 430 is configured to compress when a minimum level of negative pressure is applied to the inner cavity 420. This minimum level of negative pressure can be at least equal to the level of negative pressure applied by the expansion force of the one or more compression members, as further described below. In some embodiments, the lowest level of negative pressure is greater than the level of negative pressure applied by the expansion force of the one or more compressible members. In some embodiments, the one or more compressible members are configured to not compress until a negative pressure of at least -45 mmHg is applied to the inner cavity 420. In other embodiments, the one or more compressible members are configured to not compress until a negative pressure of at least -70 mmHg is applied to the inner cavity 420. In still other embodiments, the one or more compressible members are configured to not compress until a negative pressure of at least -200 mmHg is applied to the inner cavity 420.

  The compressed one or more compression members that make up the permeable layer 430 are then configured to exert an expansion force in the internal cavity 420 that creates a level of negative pressure that can be transmitted to the wound. In some embodiments, when one or more compressible members are compressed, the one or more compressible members elastically deform so that the expansion force exerted by the one or more compressible members is Corresponding to the stiffness of the one or more compressible members. The stiffness of the one or more compressible members is preferably such that when compressed, the compressed members are sufficiently stiff to exert an expansion force that applies the desired level of negative pressure. However, it is preferred that the one or more compressible members are not so stiff that removal of air from the internal cavity 420 cannot compress the one or more compressible members. Since the expansion force exerted by the one or more compressible members corresponds to the stiffness of the one or more compressible members, one can be selected by selecting one or more compressible members with the appropriate stiffness. Alternatively, the expansion force exerted by the plurality of compressible members can be changed.

  Referring again to FIG. 4A, the expansion force generated by one or more compressible members against the internal cavity 420 applies a negative pressure of at least −45 mmHg to the wound. In other embodiments, the expansion force generated by one or more compressible members against the internal cavity 420 applies a negative pressure of at least -70 mmHg to the wound. In yet other embodiments, the expansion force generated by one or more compressible members against the internal cavity 420 applies a negative pressure between about −20 mmHg and about −200 mmHg to the wound.

  The wound dressing 400 shown in FIGS. 4A-4C can be used to treat a patient's wound site. It is preferred that the healthy skin around the wound site be cleaned and excess hair removed or shaved. The wound site may be washed with sterile saline if necessary. Optionally, a skin protectant may be applied to the skin surrounding the wound site. If necessary, a wound packing material such as foam or gauze may be placed at the wound site. This may be preferred when the wound site is a deep wound.

  After the skin surrounding the wound site has dried, the wound dressing 400 can be positioned and positioned to cover the wound site. Preferably, the wound dressing 400 is disposed with the wound contact layer 460 covering and / or in contact with the wound site. In some embodiments, an adhesive layer is provided on the lower surface of the wound contact layer 460, which in some cases is removed prior to placing the wound dressing 400 over the wound site. It can be protected by an optional release layer. To help ensure sufficient sealing of the TNP, the edges of the dressing 400 are preferably smoothed to avoid wrinkling or bending.

  After the wound dressing 400 is secured over the wound site, the wound dressing 400 can be manipulated to apply negative pressure to the wound. A sufficient amount of air is removed from the internal cavity 420 of the wound dressing 400 by any suitable mechanism as described above. For example, the user may apply a uniform pressure to the upper surface of the wound dressing 400 by hand. By removing a sufficient amount of air, the permeable layer 430 comprising one or more compressible members is compressed as described above. The compressed one or more compressible members that make up the permeable layer 430 are then configured to exert an inflating force within the internal cavity 420 that creates a level of negative pressure that is subsequently applied to the wound site. .

  Treatment of the wound site is preferably continued until the wound reaches the desired level of healing. The level of negative pressure at the wound site may decrease over time, which is in part a slight amount that may occur at the seal between the wound dressing 400 and the skin surrounding the wound site. It may be due to a leak. As the level of negative pressure at the wound site decreases, the wound dressing 400 can be recompressed to evacuate the air and continue to apply the desired level of negative pressure to the wound site. The wound dressing 400 can be manipulated multiple times as described above to apply a desired level of negative pressure to the wound site, as one skilled in the art may consider it necessary. In some embodiments, the negative pressure device and method described herein is a second negative pressure source (miniature pump) that can be incorporated on or within the wound dressing or compressible negative pressure source described above. Etc.). Alternatively, the second negative pressure source can be fluidly connected to either the wound dressing or the compressible negative pressure source. This pump can be, for example, a micropump 110 described in US Patent Application Publication No. 2014/0249493 or a pump 170 described in US Patent Application Publication No. 2014/0228791, both of which are hereby incorporated by reference in their entirety. It can be a micropump or a small pump. The miniature pump can also be a pump similar to the pumps described in US Patent Publication Nos. 2013/0110058 and 2015/0100045 and WO2013 / 136181, which are incorporated herein by reference in their entirety.

  When fluidly connected to the compressible negative pressure source 100 shown in FIGS. 1A-1C, the pump communicates with the internal cavity 120 via a port, valve, hole, or opening in the fluid-impermeable outer membrane 110. be able to. A negative pressure can be applied to the internal cavity 120 through the opening using a pump. In some embodiments, the pump may be integrated with the compressible negative pressure source 100. For example, the pump can be mounted on the fluid impermeable outer membrane 110. The pump can be mounted on the fluid impermeable outer membrane 110 using, for example, a pressure sensitive adhesive or a UV adhesive.

  In some other embodiments, the pump can be located within the inner cavity 120 and can communicate with the surrounding environment via a port, valve, hole, or opening in the fluid-impermeable outer membrane 110. . This opening may allow the pump to exhaust air from the internal cavity 120 into the surrounding environment, thereby creating a negative pressure within the internal cavity 120. In some embodiments, the pump can be surrounded by or encapsulated within the spacer layer 130. In other embodiments, the pump can be positioned above or below the spacer layer 130 within the internal cavity 120.

  The pump can be configured to regulate the negative pressure applied to the internal cavity 120 of the compressible negative pressure source 100. That is, in some embodiments, the pump is configured to selectively turn on or off to adjust the level of negative pressure applied to the internal cavity 120. The pump can be configured to automatically turn on or start in response to the level of negative pressure in the internal cavity 120 rising above the first threshold, and the internal cavity 120 It can be configured to selectively turn off, i.e. stop, in response to the level of the negative pressure falling below the second threshold. The pump can also be configured to be manually activated and deactivated by the user.

  In use, the pump can be activated to remove a sufficient amount of air from the internal cavity 120 of the compressible negative pressure source 100. By removing a sufficient amount of air, the spacer layer 130 including one or more compressible members is compressed as described above. The compressed one or more compressible members that make up the spacer layer 130 are then configured to exert an expansion force in the internal cavity 120 that produces a level of negative pressure that is then applied to the conduit. To the wound dressing 310. This negative pressure is then applied to the wound site 301 by the wound dressing 310. When the level of negative pressure in the internal cavity rises above the first threshold, the pump will automatically start and remove air from the internal cavity 120 until the desired level of negative pressure is reached, Once reached, the pump can be turned off automatically. Such a cycle can be repeated multiple times to continue applying negative pressure to the wound site 301, as one skilled in the art may consider it necessary.

  The internal cavity 120 can act as a negative pressure reservoir that can act to increase the time that the pump is off. That is, the compressible negative pressure source 100 can apply a desired level of negative pressure to a desired location, such as the wound dressing 310, over a longer period than can be achieved with a pump alone. By reducing the time that the pump may operate or need to be on to apply the desired level of negative pressure to the desired location, the compressible negative pressure source 100 is It may be difficult to get in the way of life.

  Alternatively, a second negative pressure source such as a miniature pump can be incorporated into the wound dressing 310 or wound dressing 400 described above. For example, the second negative pressure source may be attached to the outer surface of the wound dressing, such as the upper layer of the wound dressing, or provided within the wound dressing (eg, below the upper layer). . The second negative pressure source can be configured to supply negative pressure to the wound site. The compressible negative pressure source described above (e.g., the negative pressure source 100 or the compressible member of the permeable layer 430) generates or maintains negative pressure at the wound site to allow time for the pump to operate or be on. Additional mechanisms can be provided for shortening.

  In still other embodiments, the second negative pressure source is located remotely or remotely from the wound dressing and is configured to connect the wound dressing to the one or more fluid conduits. This second negative pressure source can provide a first mechanism for supplying negative pressure to the wound site, and the compressible negative pressure source described above supplies negative pressure to the wound site or at the wound site. A second mechanism for maintaining negative pressure can be provided. This can reduce the time during which the second negative pressure source operates or needs to be on.

  Although this disclosure describes particular embodiments, those of ordinary skill in the art will appreciate that various aspects of the methods and devices shown and described in this disclosure can be combined and / or modified in various ways. It will be appreciated that acceptable embodiments can be formed. All such modifications and variations are intended to be included herein within the scope of this disclosure. Indeed, a wide variety of designs and approaches are possible and within the scope of this disclosure. The features, structures, or steps disclosed herein are not essential or essential. Furthermore, although exemplary embodiments have been described herein, those of ordinary skill in the art will recognize, based on the present disclosure, equivalent elements, modifications, omissions, combinations (eg, combinations of various aspects spanning various embodiments), It will be understood that any embodiment having substitutions, adaptations, and / or modifications and the scope of all embodiments. Although specific embodiments have been described, these embodiments have been presented for purposes of illustration only and are not intended to limit the scope of protection.

  A feature, material, characteristic, or group described in connection with a particular aspect, embodiment, or example is not intended to imply any other aspect, embodiment, or implementation described in this or other parts of this specification. It should be understood that the examples are applicable except where they are incompatible. All features disclosed in this specification (including any appended claims, abstracts, and drawings), and / or all steps of any method or process disclosed herein, Combinations can be made in any combination, except combinations where at least some of the features and / or steps are mutually exclusive. Protection is not limited to the details of any of the above embodiments. Protection is disclosed in any novel or any novel combination of features disclosed in this specification (including any appended claims, abstracts, and drawings), or in this specification. It covers any new or any new combination of steps of any method or process that does.

  Furthermore, certain features described in this disclosure in the context of separate embodiments can also be implemented in combination in one embodiment. Conversely, various features that are described in the context of one embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although various features may be described as acting in a particular combination above, one or more features of a claimed combination may be deleted from the combination, possibly subtracting the combination. May be claimed as a variation of a general combination or partial combination.

  Furthermore, although various operations may be illustrated in the drawings in a particular order or described herein, these operations may or may not be performed in the particular order or sequence shown. The desired result can be obtained without executing all of the above. Other operations not shown or described may be incorporated into the illustrated methods and processes. For example, one or more additional operations can be performed before, after, simultaneously with, or between any of the described operations. Furthermore, these operations can be rearranged or reordered in other embodiments. Those skilled in the art will appreciate that in some embodiments, the actual steps performed in the illustrated and / or disclosed process may differ from the steps shown in the drawings. Depending on the embodiment, certain of the above steps may be removed or other steps may be added. Furthermore, the features and characteristics of the specific embodiments disclosed above can be combined in various ways to form additional embodiments, and such additional embodiments are also within the scope of the disclosure. Also, the separation of various system components in the embodiments described above should not be understood as such separation is required in all embodiments, and the components and systems described are generally It should be understood that they can be integrated into a single product or packaged into multiple products.

  For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not all such advantages are necessarily realized in any particular embodiment. Thus, for example, those skilled in the art will appreciate that the present disclosure realizes one or several advantages taught herein, but does not necessarily realize other advantages that may be taught or suggested herein. It will be understood that it can also be implemented or carried out.

  The expression of a condition such as “can”, “can”, “may”, “may” is understood unless otherwise stated or in the context in which it is used. Unless otherwise indicated, other embodiments generally do not include those features, elements, and / or steps, but are intended to suggest that certain embodiments include certain features, elements, and / or steps. Has been. Thus, the expression of such a condition generally indicates that a feature, element, and / or step is required in any way for one or more embodiments, or one or more embodiments are Logic to determine whether those features, elements, and / or steps are included in any particular embodiment or performed in any particular embodiment, with or without input or prompting by It does not mean that it must be included.

  A representation of a connection, such as “at least one of X, Y, and Z” generally means that an item, term, etc. is X unless stated otherwise or understood otherwise in context. , Y, or Z is used to suggest that it may be either. Thus, such a representation of a connection generally requires that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z be present. It doesn't mean.

  As used herein, expressions such as “approximately”, “about”, “approximately”, and “substantially” are used herein to approximate the value, amount, or characteristic being described, Represents a value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms `` approximately '', `` about '', `` approximately '', and `` substantially '' refer to less than 10%, less than 5%, less than 1%, less than 0.1%, and 0.01 May refer to an amount less than%. As another example, in certain embodiments, the terms “substantially parallel” and “substantially parallel” are 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree from a completely parallel state. Hereinafter, a value, quantity, or characteristic that deviates by 0.1 degrees or less.

  The scope of the present disclosure is not limited by the specific disclosure of the preferred embodiments in this or other portions of the specification, but is presented in this portion or other portions of the specification, or presented later. Can be defined by the following claims. The language of the claims should be interpreted broadly based on the language used in the claims, and is limited to the examples described herein or described in the procedures of this application. Rather, these examples are to be interpreted as non-exclusive.

100 Compressible negative pressure source
110 Fluid-impermeable outer membrane
111 Boundary area
112 Uplift central region
120 Internal cavity
130 Spacer layer
140 Pipe material
201 Upper layer
202 Monofilament fiber spacer
203 Bottom layer
300 Wound treatment device
301 Wound site
310 Wound dressing
311 Wound contact layer
360 conduit
370 Regulating valve
400 Wound dressing
410 Fluid-impermeable outer membrane
411 Boundary area
412 Central uplift area
420 Internal cavity
430 Transmission layer
440 pipe
450 Absorbent layer
460 Wound contact layer
461 drilling

Claims (34)

A wound treatment device comprising a flexible member configured to apply negative pressure to a wound comprising:
The flexible member is
A fluid impermeable outer membrane defining an internal cavity;
One or more compressible members disposed within the internal cavity, the one or more compressible members configured to compress when air is removed from the internal cavity;
Wound treatment wherein the one or more compressible members are configured to exert an expansion force in the internal cavity that applies a desired level of negative pressure to the wound after removing air from the internal cavity. apparatus.   The flexible member is a wound dressing further comprising a wound contact layer, and the one or more compressible members are defined between the fluid impermeable outer membrane and the wound contact layer. The device of claim 1, wherein the device is disposed within the internal cavity.   The device of claim 2, wherein the wound dressing further comprises a superabsorbent layer on the one or more compressible members.   The fluid impermeable outer membrane includes a fluid impermeable upper membrane and a fluid impermeable lower membrane, wherein the upper membrane and the lower membrane are sealed together, and the The device of claim 1, wherein the device forms an internal cavity.   The device of claim 1, wherein the fluid impermeable outer membrane includes a bag defining the internal cavity.   And further comprising a separate wound dressing configured to be positioned on the wound, wherein the flexible member is in fluid communication with the separate wound dressing and is hidden from the wound through the separate wound dressing. 6. The device according to any one of claims 1, 4, and 5, wherein the device is configured to apply pressure.   The apparatus of claim 6, wherein the flexible member is configured to be wearable on a user's body.   A conduit in fluid communication with the internal cavity of the flexible member and configured to transmit negative pressure generated by the expansion force of the one or more compressible members to the separate wound dressing. The apparatus of claim 6, further comprising:   9. The device of claim 8, further comprising a regulating valve that regulates the negative pressure supplied to the wound dressing by the internal cavity of the flexible member via the conduit.   The apparatus of claim 9, wherein the internal cavity of the flexible member applies at least −400 mmHg to the regulating valve.   11. The apparatus according to any one of claims 1 to 10, wherein the one or more compressible members include a plurality of constant tension springs.   12. A device according to any one of the preceding claims, wherein the 3D knitted or fabric material incorporates a plurality of compressible members.   13. The apparatus of claim 12, wherein the 3D knitted or fabric material includes a first fabric layer and a second fabric layer and a plurality of spacer elements extending therebetween.   13. The apparatus of claim 12, wherein the 3D knitted or fabric material includes a top textured polyester layer, a bottom flat polyester layer, and a third fibrous layer sandwiched therebetween.   11. The device according to any one of claims 1 to 10, wherein the one or more compressible members comprise foam.   16. The device according to any one of claims 1-15, wherein the one or more compressible members are configured to exert an expansion force in the internal cavity that applies at least -45 mmHg to the wound.   17. The tube of any one of claims 1 to 16, further comprising a tube connected to the flexible member, wherein the tube forms a leak that allows air to be removed from the internal cavity. Equipment.   The apparatus according to any one of the preceding claims, further comprising a valve configured to regulate the removal of air from the internal cavity.   19. Apparatus according to any one of the preceding claims, wherein the flexible member is configured to allow removal of air from the internal cavity by squeezing the flexible member.   20. The apparatus according to any one of claims 1 to 19, further comprising a negative pressure source configured to remove air from the internal cavity.   21. The apparatus of any one of claims 1 to 20, further comprising a port in fluid communication with the internal cavity, wherein the port is configured to communicate with a negative pressure source.   22. The audible alarm system further comprising an audible alarm system configured to sound when the pressure in the internal cavity of the flexible member rises above a predetermined negative pressure. The device according to any one of the above. Providing a flexible member comprising a fluid impermeable outer membrane defining an internal cavity and one or more compressible members disposed within the internal cavity;
Removing air from the internal cavity, and compressing the one or more compressible members by removing air;
After removing air from the internal cavity, the one or more compressible members exert an expansion force in the internal cavity to generate a negative pressure at a desired location.   24. Air is removed from the internal cavity via tubing connected to the flexible member, and the tubing forms a leak that allows air to be removed from the internal cavity. The method described in 1.   24. The method of claim 23, wherein removing air from the internal cavity comprises removing air from the internal cavity via a negative pressure source in fluid communication with the internal cavity.   24. The method of claim 23, wherein removing air from the internal cavity comprises squeezing the flexible member.   27. A method according to any one of claims 23 to 26, wherein the one or more compressible members comprise foam.   27. A method according to any one of claims 23 to 26, wherein the one or more compressible members comprise a plurality of constant tension springs.   27. A method according to any one of claims 23 to 26, wherein the 3D knitted or fabric material incorporates a plurality of compressible members.   28. A method according to any one of claims 23 to 27, further comprising adjusting the removal of air from the internal cavity by a valve.   31. The method of any one of claims 23 to 30, further comprising monitoring pressure in the internal cavity and sounding an audible alarm when the pressure in the internal cavity rises above a predetermined negative pressure. The method according to item.   32. The method of any one of claims 23-31, wherein the one or more compressible members exert an expansion force in the internal cavity that applies at least -45 mmHg to the desired location.   33. The method of any of claims 23 to 32, further comprising adjusting the amount of negative pressure generated at a desired position by a regulating valve, wherein the regulating valve is disposed between the flexible member and the desired position. The method according to any one of the above.   34. The method of claim 33, wherein the one or more compressible members exert an expansion force in the internal cavity that applies at least -400 mmHg to the regulator valve.

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